TuberculosisVOTNCT05994144
"Conducting A Study On Video Observed Therapy In The Management Of Tuberculosis"
A study testing VIDEO OBSERVED THERAPY in people with Tuberculosis, run by University of Malaya at 1 site in Malaysia.
Trial summary
The aim of this study is to measure the effectiveness usage of VOT in the treatment of TB in terms of treatment adherence. The study will be a randomized controlled trial and will involve 240 TB patients. The study is aimed to commence by December 2023. The study period will be for 4 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis
- What is being tested?
- VIDEO OBSERVED THERAPY
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Dec 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All PTB smear-positive patients. ii. Patients aged 18 years and above. iii. Possess a digital phone or other equivalent gadget equipped with a WhatsApp application.
- Able to accurately identify each TB medication.
Who cannot join
- Recurrent PTB infection. ii. Patients who are extremely ill, have no proper social support, no caretakers, and are hospitalized.
- Patients in prison during the time of diagnosis or treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Effectiveness of Video Observed Therapy in the Management of Tuberculosis"
The aim of this study is to measure the effectiveness usage of VOT in the treatment of TB in terms of treatment adherence. The study will be a randomized controlled trial and will involve 240 TB patients. The study is aimed to commence by December 2023. The study period will be for 4 months.
Read the detailed description
There is an urgent need to produce an integrated e-health system in tackling the issue of remote monitoring for patient adherence. For example, in TB infection which requires close monitoring for better treatment outcomes. The usage of digital health products replacing the traditional DOTS will be a cost-effective method and will also bode convenient for patients and staff.
Video Observed Therapy (VOT) usage as the alternative digital health method replacing traditional DOTS will be more effective in tackling adherence issues. This method has already been tried in many countries like the United States of America (USA), the United Kingdom (UK), Italy, and Moldova, and has proven to be more effective than traditional DOTS.
For instance, a study by Story et al. reveals that a total of 70% of patients on VOT successfully completed ≥80% of a 2-month observation compared with only 31% of those on traditional DOTS (95% CI 3.10 to 9.68). A proposed intervention of adapting VOT in TB treatment is a practical move, as it can improve treatment compliance and also has the added benefit of being cost-effective.
1.4 Research Question What is the effectiveness of Video Observed Therapy (VOT) in the management of tuberculosis (TB) compared to the traditional Directly Observed Treatment Short Course Strategy (DOTS)?
1.5 Study Objectives
1.5.1 General Objective The general objective of this study is to compare the effectiveness of VOT with traditional DOTS in the management of TB.
1.5.2 Specific Objectives I. To develop VOT intervention in the management of TB. II. To compare the effectiveness of VOT as compared to traditional DOTS. III. To measure patient satisfaction using VOT.
- Conditions
- Tuberculosis
- Being tested
- VIDEO OBSERVED THERAPY
- Keywords
- Tuberculosis, Digital health, video observed therapy, treatment adherence
- Medical subject headings
- Tuberculosis, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIDEO OBSERVED THERAPYOther
Video-observed therapy is the usage of teleconferencing to observe anti-TB medication ingestion.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | No intervention | The control group, traditional DOTS is the group who will be attending daily to their respective PR-1/PR-2 throughout intensive phase. |
| INTERVENTION ARM (VOT) | Active comparator | The intervention group, video observed therapy (VOT) is the group who will be teleconferencing daily with their respective PR-1/PR-2 TB team via WhatsApp throughout the intensive phase. Receives: Other: VIDEO OBSERVED THERAPY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment adherence in percentage from both arms
Number of days medicine consumed/over 60 days intensive period
Measured: 60 days
Secondary outcomes (6)
Seroconversion rate
Number of successful sero-conversion patients from sputum smear positive to sputum smear negative by the end of the intensive phase.
Measured: 60 days
Side effects incidents report
Number of reported side effects detected from both arms.
Measured: 60 days
Patients suffering with side effects
Number of patients having side effects detected from both arms.
Measured: 60 days
Degree of patient's satisfaction
The degree of satisfaction of the participants from both arms.
Measured: Questionnaire using Likert scale. "Score 1:least satisfied,Score 5: most satisfied"
Time save
Overall time spent by patients from both arms.
Measured: 120 days
Cost saving
Overall money spent by patients from both arms.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start1 Dec 2023 (estimated)
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- For all participants who are randomised into VOT arm or traditional DOTS arm. Control group : Patients allocated into the traditional DOTS arm will follow the usual protocol as all other patients assigned to DOTS under Ministry of Health Malaysia Intervention group : Patient will be observed on their daily TB medication consumption via teleconference by using WhatsApp video call.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994144
- Sponsor's protocol ID
- AISH7
- Acronym
- VOT
- Status last verified
- May 2023
- First submitted
- 19 Jul 2023
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD WILL NOT BE SHARED FOR UNSPECIFIED REASONS
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effectiveness of Video Observed Therapy in the Management of Tuberculosis"
- ClinicalTrials.gov ID
- NCT05994144
- Acronym / sponsor ID
- VOT / AISH7
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, Digital health, video observed therapy, treatment adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to measure the effectiveness usage of VOT in the treatment of TB in terms of treatment adherence. The study will be a randomized controlled trial and will involve 240 TB patients. The study is aimed to commence by December 2023. The study period will be for 4 months.
Detailed description
There is an urgent need to produce an integrated e-health system in tackling the issue of remote monitoring for patient adherence. For example, in TB infection which requires close monitoring for better treatment outcomes. The usage of digital health products replacing the traditional DOTS will be a cost-effective method and will also bode convenient for patients and staff.
Video Observed Therapy (VOT) usage as the alternative digital health method replacing traditional DOTS will be more effective in tackling adherence issues. This method has already been tried in many countries like the United States of America (USA), the United Kingdom (UK), Italy, and Moldova, and has proven to be more effective than traditional DOTS.
For instance, a study by Story et al. reveals that a total of 70% of patients on VOT successfully completed ≥80% of a 2-month observation compared with only 31% of those on traditional DOTS (95% CI 3.10 to 9.68). A proposed intervention of adapting VOT in TB treatment is a practical move, as it can improve treatment compliance and also has the added benefit of being cost-effective.
1.4 Research Question What is the effectiveness of Video Observed Therapy (VOT) in the management of tuberculosis (TB) compared to the traditional Directly Observed Treatment Short Course Strategy (DOTS)?
1.5 Study Objectives
1.5.1 General Objective The general objective of this study is to compare the effectiveness of VOT with traditional DOTS in the management of TB.
1.5.2 Specific Objectives I. To develop VOT intervention in the management of TB. II. To compare the effectiveness of VOT as compared to traditional DOTS. III. To measure patient satisfaction using VOT.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- For all participants who are randomised into VOT arm or traditional DOTS arm. Control group : Patients allocated into the traditional DOTS arm will follow the usual protocol as all other patients assigned to DOTS under Ministry of Health Malaysia Intervention group : Patient will be observed on their daily TB medication consumption via teleconference by using WhatsApp video call.
| Arm | Type | Receives |
|---|---|---|
| CONTROL | No intervention | –The control group, traditional DOTS is the group who will be attending daily to their respective PR-1/PR-2 throughout intensive phase. |
| INTERVENTION ARM (VOT) | Active comparator | Other: VIDEO OBSERVED THERAPYThe intervention group, video observed therapy (VOT) is the group who will be teleconferencing daily with their respective PR-1/PR-2 TB team via WhatsApp throughout the intensive phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All PTB smear-positive patients. ii. Patients aged 18 years and above. iii. Possess a digital phone or other equivalent gadget equipped with a WhatsApp application.
- Able to accurately identify each TB medication.
Key exclusion criteria (2 listed)
- Recurrent PTB infection. ii. Patients who are extremely ill, have no proper social support, no caretakers, and are hospitalized.
- Patients in prison during the time of diagnosis or treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIDEO OBSERVED THERAPYVideo-observed therapy is the usage of teleconferencing to observe anti-TB medication ingestion. | Other | INTERVENTION ARM (VOT) |
Primary outcome
Treatment adherence in percentage from both arms
Time frame: 60 days
Number of days medicine consumed/over 60 days intensive period
6 secondary outcomes
Seroconversion rate
Time frame: 60 days
Side effects incidents report
Time frame: 60 days
Patients suffering with side effects
Time frame: 60 days
Degree of patient's satisfaction
Time frame: Questionnaire using Likert scale. "Score 1:least satisfied,Score 5: most satisfied"
Time save
Time frame: 120 days
Cost saving
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Individual participant dataSharing planned: No. IPD WILL NOT BE SHARED FOR UNSPECIFIED REASONS
Related trials for Tuberculosis
RecruitingPhase 4
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Tuberculosis
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIDEO OBSERVED THERAPY in people with Tuberculosis, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact KARTIK KALIYANA SUNDARAM, MPH (0060124975343, kartik25@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment adherence in percentage from both arms (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.